Results from a Phase 2 trial assessing the safety and efficacy of anabasum (formerly known as Resunab or JBT-101) shows promise in treating systemic sclerosis. That study is now being extended, and a Phase 3 trial is being planned.

Anabasum, Corbus Pharmaceuticals’ lead candidate, is a synthetic oral drug that binds to receptors expressed on activated immune cells and fibroblasts. The drug triggers the production of “specialized pro-resolving lipid mediators,” a cellular cascade of signals that work to inhibit inflammation and stop fibrosis without causing immunosuppression.

Preclinical and clinical studies have demonstrated anabasum’s safety and tolerability. Results of a Phase 2 (NCT02465437) clinical trial in diffuse cutaneous systemic sclerosis reported by the company in November 2016 showed that anabasum could have beneficial clinical effects for this condition.

Evaluation of modified Rodnan Skin Score (mRSS), as a measure of skin thickening and a validated clinical outcome measure in systemic sclerosis, showed that anabasum-treated patients had less skin involvement than those given placebo. This effect was accompanied by significant improvements in skin symptoms and reduced expression of genes associated with inflammation and fibrosis in skin biopsies.

A 12-month and open-label extension of this study is ongoing to further confirm these findings in systemic sclerosis patients given anabasum at 20 mg twice a day, according to a press release.

These positive clinical results support the continued development of anabasum for the treatment of systemic sclerosis, the company said. Corbus expects to initiate a placebo-controlled Phase 3 study in late 2017, with assistance from the European Medicines Agency on the study design.

This Phase 3 trial is expected to enroll about 270 adults with diffuse cutaneous systemic sclerosis, who will receive anabasum 20 mg or 5 mg twice per day, or placebo, for 52 weeks. Corbus expects interim results to be available in late 2019. If the trial is successful, the company plans to file requests with regulatory agencies for anabasum to be approved as a systemic sclerosis treatment in 2020.

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